Results from the TALENT trial could have economic implications in countries like India where there are caps on stent pricing, as well as some European countries with competitive pricing and/or different models of health care cost saving, said researchers presenting at TCT 2018.

TALENT, led by Patrick W. Serruys, MD, PhD, FACC, randomized an "all-comers" population of 1,435 patients to either the Supraflex biodegradable polymer sirolimus-eluting stent (SES) (N=720) manufactured in India or the widely-used Xience durable polymer everolimus-eluting stent (EES) (N=715). The primary endpoint was non-inferiority comparison of device-oriented composite endpoint (DOCE), a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesions revascularization, at 12 months.

Results found the Supraflex SES stent to be non-inferior to the Xience EES in terms of DOCE at 12 months (4.9 percent vs. 5.3 percent, respectively). Researchers also observed a lower rate of clinically-indicated target lesion revascularization in the per-protocol analysis of the Supraflex SES group (p=0.021).

Based on these results, "market competitiveness may influence future decision on which stent to use" in some countries, researchers noted. They specifically highlighted India's new pricing cap policy for stents that took effect in February 2017 and cited a June 2017 editorial published in EuroIntervention from Upendra Kaul, MD, DM, FACC, of the Fortis Escorts Heart Institute, New Delhi, India, that suggests trials like TALENT could be good for country-specific manufacturers if they can show non-inferiority of their products.

Kaul wrote: "One positive effect of this pricing cap is likely to be an increase in the use of indigenously manufactured stents which currently have a market share of less than 40 percent ... It is therefore time for these companies to prove to the cardiologists and the patients the equivalent safety and efficacy of their products when compared with products from multinational companies that would have undergone vigorous testing in adequately powered clinical trials. There is a perception in the minds of cardiologists, which gets passed on to the patients, that imported stents are superior."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Angiography, Drug-Eluting Stents, Polymers, Absorbable Implants

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